Long-Term Comparative Effectiveness of the Lap Band

描述（由申请人提供）：臀带手术治疗病态肥胖的长期比较有效性呈指数增长，现在是美国第二大最常见的腹部手术。增长的很大一部分是由腹腔镜可调节胃束带（Lap Band）使用的急剧增加所驱动的。然而，越来越多的人担心Lap Band的长期安全性和有效性。有新的证据表明，晚期并发症的发生率很高（在某些病例系列中高达30%），包括带糜烂和滑脱。此外，许多人担心，因为在现实世界中，与早期试验相比，在减肥和解决合并症方面，Lap Band并没有那么有效。最后，在安全性和有效性方面是否存在异质性，无论是跨患者亚组还是跨提供者特征，都没有得到严格的评估。医疗保险和医疗补助服务中心（CMS）最近的一项政策变化，即2006年全国范围内对减肥手术的覆盖决定，为评估Lap Band的长期相对有效性提供了一个独特的自然实验。实践中的变化可以作为一个工具变量来减轻在比较Lap Band和腹腔镜胃旁路（金标准减肥手术）时的选择偏差。我们有以下三个具体目标：目标1。评估膝带在医保患者中的相对长期安全性。使用国家医疗保险人群，我们将评估Lap Band与腹腔镜胃旁路手术的长期安全性。具体来说，我们将评估90天、1年和5年的再手术率和初次手术并发症的住院率。目标2。目的：评价膝带在医保患者中的长期疗效。使用全国医疗保险人群，我们将评估Lap Band对医疗保健服务和与肥胖相关的合并症的相关医疗保险支付的影响。目标3。评估在医疗保险患者中腰束带的安全性和有效性的异质性。由于Lap Band对不同的亚组可能或多或少有益，我们将从安全性和有效性方面评估其对不同年龄、基线健康状况和选择合并症的患者的有效性。我们将评估Lap Band在不同提供者特征（例如，经验丰富或数量较少的医院和外科医生）中有效性的异质性。这项研究的结果将最直接地影响医疗保险和医疗补助服务中心（CMS）以及他们对减肥手术的全国覆盖决定。CMS积极地重新评估肥胖覆盖率，并准确估计Lap Band与其他程序相比在现实世界中的安全性和有效性，这将有助于他们基于证据的覆盖决策。患者将是这项研究的最终受益者，因为他们将更好地了解Lap Band的真正长期风险和益处。

DESCRIPTION (provided by applicant): Long-term comparative effectiveness of the Lap Band Surgery for morbid obesity has grown exponentially and is now the 2nd most common abdominal operation in the United States. A large part of the growth has been driven by the dramatic increase in the use of laparoscopic adjustable gastric banding (Lap Band). However, there are growing concerns about the longer term safety and effectiveness of the Lap Band. There is emerging evidence of high rates (up to 30% in some case series) of late complications, including band erosion and slippage. Moreover, many are concerned because the Lap Band has not been as effective, in terms of weight loss and comorbid disease resolution, in the real world as compared to early trials. Finally, whether there is heterogeneity in safety and effectiveness, either across patient subgroups or provider characteristics, has not been rigorously assessed. A recent policy change by the Center for Medicare and Medicaid Services (CMS), the 2006 national coverage decision for bariatric surgery, provides a unique natural experiment for evaluating the long-term comparative effectiveness of the Lap Band. The change in practice can be used as an instrumental variable to mitigate selection bias in comparing the Lap Band vs. laparoscopic gastric bypass, the gold-standard weight loss procedure. We have the following three Specific Aims: Aim 1. To evaluate the comparative long-term safety of the Lap Band in Medicare patients. Using the national Medicare population, we will evaluate the long term safety of the Lap Band compared to laparoscopic gastric bypass surgery. Specifically, we will evaluate 90-day, 1-year, and 5-year reoperation and hospitalization rates for complications of the initial surgery. Aim 2. To evaluate the comparative long-term effectiveness of the Lap Band in Medicare patients. Using the national Medicare population, we will evaluate the impact of the Lap Band on healthcare services and related Medicare payments for obesity-related comorbid conditions. Aim 3. To evaluate heterogeneity in the safety and effectiveness of the Lap Band in Medicare patients. Because the Lap Band may be more or less beneficial for different subgroups, we will evaluate its effectiveness, in terms of safety and effectiveness, for patients with different age, baseline health status, and select comorbid diseases. We will evaluate heterogeneity in the effectiveness of the Lap Band across different provider characteristics (e.g., hospitals and surgeons with more vs. less experience or volume). Results from this study will most immediately impact the Center for Medicare and Medicaid Services (CMS) and their national coverage decision for bariatric surgery. CMS actively re-evaluates bariatric coverage and accurate estimates of real- world safety and effectiveness of Lap Band compared to other procedures will help their evidence-based coverage decisions. Patients will be the ultimate beneficiaries of this research as they will be better informed regarding the true long term risks and benefits of the Lap Band.